Michael Page
Location
Secunderabad | India
Job description
. Directs and delegates to assigned Global Trial Management staff as applicable.
. Drives study execution utilizing available performance metrics and quality indicators (e.g. CTMS, eTMF reports, RBM reports), and study milestones and drivers.
. Develops, manages, and maintains study deliverables (i.e. timelines, study plans, etc.) through collaboration with internal and external stakeholders using data and strong interpersonal influencing skills to make robust data driven decisions.
. Proactively identifies potential risks, develops/implements actions, and makes the appropriate trade-offs of balancing risks with study deliverables and costs.
. Maintains and updates data as appropriate in project management tools including CTMS.
. Informs operational program lead(s) and other leadership (as appropriate) on overall clinical trial plans and recruitment status and raises potential issues/mitigation.
. Requires minimal oversight to lead/manage projects.
. Identifies, participates and/or leads initiatives with cross-functional/global teams.
. Leads Study Team meetings, defines the agenda, captures meeting minutes, and facilitates cross-functional discussions.
. Creates, maintains, and implements project management tools at the study level (e.g. actions, decisions, issues log and risk management plan).
. Provides input to data, protocol deviation review, and patient tracker.
. Provides strategic input into Study Team - e.g., on study documents. Collaborates with CSO on global investigational product [IP] supply forecasting/management.
. Participates in the subject recruitment/retention strategy and related initiatives (e.g. recruitment material).
. Participates in clinical service provider (vendor) selection, specification development, and management / oversight.
. Oversees TMF set-up, ongoing quality review, and operational oversight memo and requests final reconciliation
. Oversees eCOA activities throughout the lifecycle of the study.
. Provides input to and reviews study training for Study Team, investigational sites, and vendors in collaboration with the Clinical Scientist.
. Oversee study specific CSR appendices.
. Provides input and communicates with the appropriate teams for response to country/regulatory and IRB/IEC.
. Promptly shares information with key internal/external stakeholders at regular meetings.
. Proactively identifies and anticipates issues and risks and oversees the creation of mitigation plans and implements resolutions.
. Oversees service providers with minimal supervision.
. Leads Audit Response Team and CAPA and participates in inspections.
. Supports the development/management/review of the vendor scope of work (SOW), invoices, accruals as per the contract, quality requirements, and budget. Study Planning and Conduct - Outsourced Studies
. Reviews/approves functional plans (e.g. SAE management plan, PSV waivers, BMS confidentiality agreement for sites with master agreements). Provides information to the CRO and reviews CRO deliverables.
. Sets up and maintains Protocol Level training curriculum in SuccessFactors.
. Reviews Protocol Level training for IM and SIV.
. Owns overall and end-to-end study project management responsibilities.
. Provides oversight and reviews all outsourced activities (protocol to CSR) in Clinical Pharmacology (NHV) studies. Relationship Management
. Proactively develops/maintains collaborative relationships with internal partners/stakeholders across the multidisciplinary teams.
. Manages external partners including Contract Research Organizations (CROs), Academic Research Organizations (AROs), and other clinical service providers as applicable.
. Ensures appropriate methods are used when communicating with key stakeholders and cross functional partners.
Degree Requirements
. BA/BS or equivalent degree in relevant discipline Experience Requirements
. Minimum 4 years of demonstrated project management experience of which at least 2 should have been in the pharmaceutical or healthcare industry.
. Experience in leading global clinical trials and multi-functional teams.
. Demonstrated project management and organizational skills with strong presentation and communication abilities.
. Experience with electronic quality, compliance and CTMS systems. Experience in managing CROs is a plus.
. Risk management experience preferred.Key Competency Requirements Technical Competencies
. Clinical trial project management skills.
. Financial budgeting and forecasting skills are a plus.
. In depth knowledge of ICH/GCP, regulatory guidelines/directives, and drug development and clinical research processes.
. Proven success in using oral/written communication skills to influence, inform, or guide others.
. Computer skills - Microsoft applications including (but not limited to), Word and Excel and PowerPoint
. Proficiency in study tools including electronic system skills - e.g. CTMS/eTMF.
. Demonstrated project management and organizational skills with strong presentation and communication abilities.
. Ability to manage multiple deliverables and nimbly respond to changing business demands.
Opportunity to work with a leading healthcare MNC
Best in-class industry experience and benefitsJob tags
Salary